NDC 57970-100

DALVANCE

Dalbavancin

DALVANCE is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Dalbavancin Hydrochloride.

• Product ID: 57970-100_948f52da-c121-4d45-9a8f-273ecd90a1da
• NDC: 57970-100
• Product Type: Human Prescription Drug
• Proprietary Name: DALVANCE
• Generic Name: Dalbavancin
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-05-23
• Marketing Category: NDA / NDA
• Application Number: NDA021883
• Labeler Name: Allergan, Inc.
• Substance Name: DALBAVANCIN HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/25mL
• Pharm Classes: Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 57970-100-01

1 VIAL in 1 PACKAGE (57970-100-01) > 25 mL in 1 VIAL

• Marketing Start Date: 2014-05-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57970-100-01 [57970010001]

DALVANCE INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021883
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-05-23

Drug Details

Active Ingredients

Ingredient	Strength
DALBAVANCIN HYDROCHLORIDE	500 mg/25mL

OpenFDA Data

• SPL SET ID: 4b4674d8-4d1e-4728-8465-d42ada33fa5c
• Manufacturer:
  • Durata Therapeutics Inc.
• UNII:
  • 33WDQ7T81E
• RxNorm Concept Unique ID - RxCUI:
  • 1539243
  • 1539248

Pharmacological Class

• Lipoglycopeptide Antibacterial [EPC]
• Lipoglycopeptides [EXT]
• Lipoglycopeptide Antibacterial [EPC]
• Lipoglycopeptides [EXT]